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Article

Pilot Study and Preliminary Results of Biodegradable Intramedullary Nailing of Forearm Fractures in Children

1
Department for Health Sciences, Medicine and Research, Danube University Krems, 3500 Krems, Austria
2
Department of Orthopedics and Trauma Surgery, Landesklinikum Baden/Moedling, 2340 Moedling, Austria
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Department of Pediatric Orthopaedics, Hospital Pediátrico de Coimbra, 3000-602 Coimbra, Portugal
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Department of Orthopedics, Hvidovre Hospital, 2650 Hvidovre, Denmark
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Department of Pediatric Orthopedic Surgery, Jeanne de Flandre Hospital, 59000 Lille, France
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Department of Orthopedics and Trauma Surgery, Helios University Hospital Wuppertal, 42283 Wuppertal, Germany
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Department of Pediatric Trauma Surgery, Dr. Manninger Jenő Baleseti Központ, 1081 Budapest, Hungary
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Service de Chirurgie de l’enfant et de l’adolescent, Centre Hospitalier Universitaire Vaudois, 1011 Lausanne, Switzerland
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Medical Centre, Department of Paediatrics, Division of Paediatric Surgery, Traumatology, Urology and Paediatric Otolaryngology, UP Clinical Centre, 7623 Pécs, Hungary
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Department of Orthopedics and Trauma, Medical University of Graz, 8036 Graz, Austria
11
Department of Pediatric Surgery, University Medical Center Schleswig-Holstein, Campus Lübeck, 23538 Lübeck, Germany
*
Author to whom correspondence should be addressed.
Academic Editors: Robert Bergholz and Thomas Franz Krebs
Children 2022, 9(5), 754; https://doi.org/10.3390/children9050754
Received: 24 February 2022 / Revised: 12 May 2022 / Accepted: 17 May 2022 / Published: 20 May 2022
(This article belongs to the Special Issue Current Development of Pediatric Minimally Invasive Surgery)
(1) Background: Diaphyseal forearm fractures are a common injury in children and adolescents. When operative treatment is needed, elastic stable intramedullary nailing (ESIN) is the most common surgical procedure. Although there is no clear evidence, hardware removal after fracture healing is performed in many patients. Often, the primary minimal invasive incision needs to be widened during implant removal. In order to decrease the burden of care of pediatric fractures, significant efforts were made to develop biodegradable implants, which make hardware removal unnecessary. Our study will conduct an observational trial on the clinical use of the Activa IM-Nail™ in forearm fractures in children between 3 and 13 years of age. The objective of this trial is to evaluate the risks and benefits of the Activa IM-Nail™. Among other objectives, the rate of refracture will be determined. (2) Methods: An international Europe-based, multicenter, prospective, single-arm, open-label study will be performed to ascertain the rate of refracture and to determine the subjective benefits of Activa IM-Nail™ for patients, parents and other caregivers. The study will include clinical follow-up including early post-operative complication, radiographs until bony healing and an additional follow-up after 1 year. At this stage, preliminary results and early complications on 76 patients are analyzed in this study and presented. (3) Results: As of April 2022, 76 patients were enrolled as per study protocol. There were 31 girls (40.8%) and 45 boys (59.2%). The mean age at the time of inclusion was 8.9 years (±2.4 years). The mean operation time was 58.9 ± 22.9 min (range, 15–119 min). The mean follow-up time was 8.9 ± 5.1 months (range, 0.2–18.6). Up to now, one refracture has occurred in one child falling from a height of about one meter 7 months after index surgery (1/76; 1.3%). (4) Conclusion: The research project assesses the safety and effectiveness of Activa IM-Nails™ as part of the surgical treatment of dislocated forearm fractures in children in the context of a PMCF study. The use of Activa IM-Nails™ with regard to various objectives, including postoperative complications and refracture rate, seems to be equal to the standard titan ESIN procedure compared to the literature. Preliminary results are encouraging and are made available. View Full-Text
Keywords: fracture; children; forearm; intramedullary nailing; bioabsorbable fracture; children; forearm; intramedullary nailing; bioabsorbable
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MDPI and ACS Style

Roeder, C.; Alves, C.; Balslev-Clausen, A.; Canavese, F.; Gercek, E.; Kassai, T.; Klestil, T.; Klingenberg, L.; Lutz, N.; Varga, M.; Jozsa, G.; Weinberg, A.; Tüshaus, L. Pilot Study and Preliminary Results of Biodegradable Intramedullary Nailing of Forearm Fractures in Children. Children 2022, 9, 754. https://doi.org/10.3390/children9050754

AMA Style

Roeder C, Alves C, Balslev-Clausen A, Canavese F, Gercek E, Kassai T, Klestil T, Klingenberg L, Lutz N, Varga M, Jozsa G, Weinberg A, Tüshaus L. Pilot Study and Preliminary Results of Biodegradable Intramedullary Nailing of Forearm Fractures in Children. Children. 2022; 9(5):754. https://doi.org/10.3390/children9050754

Chicago/Turabian Style

Roeder, Christoph, Cristina Alves, Andreas Balslev-Clausen, Federico Canavese, Erol Gercek, Tamás Kassai, Thomas Klestil, Louise Klingenberg, Nicolas Lutz, Marcell Varga, Gergo Jozsa, Annelie Weinberg, and Ludger Tüshaus. 2022. "Pilot Study and Preliminary Results of Biodegradable Intramedullary Nailing of Forearm Fractures in Children" Children 9, no. 5: 754. https://doi.org/10.3390/children9050754

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